Objective: To study the efficacy of SDR in spastic diplegia. Design: Single center investigator-masked randomized clinical trial. Subjects: 43 children were randomized to receive SDR plus physical therapy (PT), or PT alone. Interventions: SDR was guided with electrophysiologic monitoring. All subjects received equivalent PT. Spasticity was measured by an electromechanical torque device (EMT) and the Ashworth scale. The Gross Motor Function Measure (GMFM) recorded changes in functional mobility. Investigator-masked outcome measures were collected at baseline, 12 and 24 months. Results: See Table. Conclusions: SDR is safe and reduces spasticity in children with spastic diplegia. SDR plus PT and equivalent PT without SDR result in equal improvements in mobility at 24 months.

Table 1